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Influence of Minimally Invasive Thymectomy on the Subsequent Clinical Course of Myasthenia Gravis
NCT04158661 · Charite University, Berlin, Germany · Updated 24 Sept 2021
- What is being tested
- thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy); thymectomy by means of median sternotomy (transsternal); no thymectomy (control)
- For
- Myasthenia Gravis
- Kind of study
- Watches patients without assigning a treatment. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 248 people. The full rules are on the registry page.
- Where
- Germany (3 sites)
- When
- Starts or started 20 April 2020, ends 30 June 2022. Registered 12 Nov 2019.
- Results
- None posted yet.
In the researchers' words
The aim of this study is to investigate whether minimally invasive thymectomy achieves comparable efficacy and safety results compared to open thymectomy in patients with myasthenia gravis. The planned investigation is a multicenter observational study based on retrospective (present patient data) and prospective data (questionable outcome data). Primary hypothesis: Minimally invasive thymectomy is not inferior to open thymectomy in terms of efficacy and safety (non-inferiority study).
Sites
- Sana Klinikum LichtenbergBerlin, Germany
- Department of Surgery Charité UniversityMitte, Germany
- NeuroCure Clinical Research Center (NCRC), Charité University, BerlinMitte, Germany